BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 19122662 · Received April 16, 2024

    Report

    Report Number
    2017233-2024-04837
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    March 27, 2024
    Report Date
    May 10, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PFV
    PMA / PMN Number
    P130006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: C19 - PROCEDURAL DEPLOYMENT OF THE VSX DEVICE CAN BE IMPACTED BY DIFFERENT FACTORS INCLUDING BUT NOT LIMITED TO ZIPPER INTEGRITY, DELIVERY SYSTEM SUPPORT OR STIFFNESS, OR PRESENCE OF DRIED FLUID ON THE DEVICE. THE INVESTIGATION COULD NOT CONFIRM THE CAUSE OF THE REPORTED HAZARDOUS SITUATION NOR ASSIGN A PRIMARY DEVICE FAILURE MODE. THE PRIMARY REPORTED COMPLAINT OF PARTIAL VSX DEPLOYMENT WITH A STUCK DEPLOYMENT LINE COULD NOT BE INDEPENDENTLY CONFIRMED WITH THE INFORMATION AVAILABLE. ONE IMAGE OF THE VSX DEVICE ASSOCIATED WITH THIS COMPLAINT WAS PROVIDED AND THE VSX DEVICE AS SHOWN IS PARTIALLY DEPLOYED WITH PARTIAL EXPANSION OF THE ENDOPROSTHESIS. HOWEVER, IT WAS REPORTED THAT THE PARTIAL EXPANSION OCCURRED AFTER WITHDRAWAL OF THE VSX DEVICE. THEREFORE, THE CONDITION OF THE VSX DEVICE IN THE IMAGE IS NO LONGER REFLECTIVE OF ITS CONDITION AT THE TIME OF THE INITIALLY REPORTED DEPLOYMENT FAILURE. THE VSX DEVICE ITSELF WAS REPORTEDLY DISCARDED AND WAS UNAVAILABLE FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED PARTIAL DEPLOYMENT WITH STUCK DEPLOYMENT LINE COULD NOT BE ESTABLISHED BASED ON THE INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    H6: B14 - A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE DEVICE MET PRE-RELEASE SPECIFICATIONS. CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A PATIENT WAS TO BE IMPLANTED WITH 8MM X 10CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) TO TREAT AVF ANGIOPLASTY. WHEN THE PHYSICIAN PULLED OUT THE DEPLOYMENT LINE, THE VIABAHN DEVICE COULDN'T BE DEPLOYED AND GOT STUCK. THE DEVICE WASN'T EXPANDED WHEN REMOVED OUT OF PATIENT. PERHAPS IT WAS OPENED ITSELF OUTSIDE OF BODY. ANOTHER VIABAHN DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1800811 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT PFV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown